Comparison of Two Different Intensities of Non-Invasive Breathing Support in Patients with Acute Worsening of Chronic Obstructive Pulmonary Disease

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: High intensity non invasive ventilation: High‐intensity NIV group: Target tidal volume 10‐15 ml/kg PBW, adjusted for patient comfort and target ABG improvement.The allocated NIV strategy (high‐intensity or low‐intensity) will be administered from the time of randomization until discontinuation of NIV as determined by predefined weaning criteria or clinical indication, for a maximum duration of 72 hours during the inde Xhospitalization Control Intervention1: Low intensity non invasive ventilation: Target tidal volume 6‐10 ml/kg PBW, adjusted for patient comfort and target ABG improvement. The allocated NIV strategy (high‐intensity or low‐intensity) will be administered from the time of randomization until discontinuation of NIV as determined by predefined weaning criteria or clinical indication, for a maximum duration of 72 hours during the inde Xhospitalization. CONDITION: Health Condition 1: J441‐ Chronic obstructive pulmonary disease with (acute) exacerbation PRIMARY OUTCOME: Mean change in PaCO2Timepoint: from baseline to 24 hours SECONDARY OUTCOME: Cumulative intubation rateTimepoint: at 24, 48, and 72 hours In hospital mortalityTimepoint: Incidence and type of NIV related adverse eventsTimepoint: at 24, 48, and 72 hours Length of ICU/IPD stayTimepoint: in days Mean change in arterial pHTimepoint: from baseline to 24, 48, and 72 hours Mean change in PaCO2Timepoint: from baseline to 48 and 72 hours NIV comfort scoreTimepoint: at 24, 48, and 72 hours Proportion of patients meeting intubation criteriaTimepoint: at 24, 48, and 72 hours Respiratory rate and SpO2 changesTimepoint: from baseline to 6, 24, 48, and 72 hours Richmond agitation sedation scale scoresTimepoint: at 24, 48, and 72 hours. INCLUSION CRITERIA: 1.Age more than equal to18 years 2.AECOPD with type II respiratory failure: PaCO2 more than 45 mmHg and pH less than7.35 3.Candidate for NIV as per guidelines
Epistemonikos ID: c7395108117244093be7875cdff17d49ed7ee91d
First added on: Oct 08, 2026